Assessing the impact of ICH E9

被引：5

作者：

Brown, David ^{[1
]}

Day, Simon ^{[2
]}

Hemmings, Rob ^{[1
]}

Wright, David ^{[1
]}

机构：

[1] Med & Healthcare Prod Regulatory Agcy, London SW8 5NQ, England

[2] Roche Prod Ltd, Welwyn Garden City AL7 1TW, Herts, England

来源：

PHARMACEUTICAL STATISTICS | 2008年 / 7卷 / 02期

关键词：

regulatory guidance; marketing authorization application; confirmatory clinical trials;

D O I：

10.1002/pst.337

中图分类号：

R9 [药学];

学科分类号：

1007 [药学];

摘要：

The ICH harmonized tripartite guideline 'Statistical Principles for Clinical Trials', more commonly referred to as ICH E9, was adopted by the regulatory bodies of the European Union, Japan and the USA in 1998. This document united related guidance documents on statistical methodology from each of the three ICH regions, and meant that for the first time clear consistent guidance on statistical principles was available to those conducting and reviewing clinical trials. At the 10th anniversary of the guideline's adoption, this paper discusses the influence of ICH E9 by presenting a perspective on how approaches to some aspects of clinical trial design, conduct and analysis have changed in that time in the context of regulatory submissions in the European Union. Copyright (C) 2008 John Wiley & Sons, Ltd.

引用

页码：77 / 87

页数：11